Status:
RECRUITING
18F-DOPA II - PET Imaging Optimization
Lead Sponsor:
University of Alberta
Conditions:
Congenital Hyperinsulinism
Neuroblastoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenit...
Detailed Description
BACKGROUND AND RATIONALE 6-\[18F\]fluoro-dihydroxyphenylalanine (18F-DOPA) is a large neutral amino acid that resembles natural L-3.4-dihydroxyphenylalanine (L-DOPA) biochemically. L-DOPA is a precur...
Eligibility Criteria
Inclusion
- Pediatric patients (less than 18 years old) with congenital hyperinsulinism.
- Pediatric patients (less than 18 years old) with neuroblastoma.
- Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor.
- Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia.
- Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors.
Exclusion
- Unable to obtain consent
- Weight \>225 kg (weight limitation of PET/CT scanner)
- Adult patients unable to lie flat for 20-30 minutes to complete the PET-CT session.
- Young pediatric patients (less than 13 years old) who are unable to lie flat for 20-30 minutes and for whom clinical sedation is contraindicated (as determined by a pediatric anaesthesiologist).
- Lack of intravenous access
- History of previous cholecystectomy (excluded from dynamic abdomen sub-study only)
- Pregnancy
Key Trial Info
Start Date :
January 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT04706910
Start Date
January 20 2021
End Date
July 1 2026
Last Update
May 7 2025
Active Locations (1)
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1
WC Mackenzie Health Science Centre / University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7